RecruitingNot ApplicableNCT06744322

Fast Discharge After Acute Myocardial Infarction Discharge MI

Fast Discharge After Acute Myocardial Infarction Discharge MI - A Randomized Multicenter Non Inferiority Trial


Sponsor

Medical University Innsbruck

Enrollment

2,070 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the hypothesis that a fast discharge strategy (discharge at 24 \[± 12\] hours) following invasive management for acute myocardial infarction is non-inferior to standard of care (\>36 hours) with respect to the risk of major adverse cardiovascular events (MACE) during follow-up.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Uncomplicated acute myocardial infarction (NSTEMI and STEMI) diagnosed according to the 2023 acute coronary syndrome guidelines of the ESC
  • Age ≥ 18 years at time of consent
  • Invasive management strategy and in case of PCI successful intervention of the culprit lesion defined by post-interventional TIMI 3 flow
  • Ability to understand and willingness to sign and date written informed consent

Exclusion Criteria10

  • Myocardial infarction complicated by cardiac arrest (out-of-hospital cardiac arrest/in-hospital cardiac arrest)
  • PCI-related complications (coronary perforation, side branch closure, inability to deliver stent/balloon, aortic dissection, allergic reaction grade ≥2, stroke/thromboembolism, access site complications including pseudoaneurysm, arteriovenous fistula, retroperitoneal hemorrhage and arterial dissection/occlusion or emboli)
  • Malignant arrhythmias including sustained ventricular arrhythmias and persistent bradycardia (\< 50 beats per minute due to sinus node or atrioventricular conduction system abnormalities, second- /third-degree atrioventricular block) after PCI
  • Ongoing hemodynamic instability (systolic blood pressure \<90 mmHg, elevated lactate concentrations, need for inotropes or vasopressors)
  • Ongoing respiratory instability defined by Killip class \>I (rales, pulmonary edema)
  • Ongoing quantitative disorders of consciousness (somnolence, sopor, coma)
  • Acute kidney injury defined by Kidney Disease Improving Global Outcomes (KDIGO) stages 2 and 3
  • Pregnancy
  • Untreated critical non-culprit lesions requiring revascularization during index hospitalization not allowing fast discharge
  • Immobility/limited mobility or social circumstances that prevent fast discharge assessed by an interprofessional care team

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Interventions

PROCEDUREFast discharge strategy

Patients undergoing invasive management after myocardial infarction will be discharged after 24 (+/- 12) hours.


Locations(8)

Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, Austria

Paracelsus Medical University Salzburg

Salzburg, Salzburg, Austria

Cardinal Schwarzenberg Hospital Schwarzach

Schwarzach im Pongau, Schwarzach Im Pongau, Austria

Medical University of Graz

Graz, Styria, Austria

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

University Teaching Hospital Wels-Grieskirchen

Wels, Upper Austria, Austria

Academic Teaching Hospital Feldkirch

Feldkirch, Vorarlberg, Austria

Ludwig Maximilian University Munich

Munich, Bavaria, Germany

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NCT06744322


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